Method and apparatus for aiding in the detection of breast cancer

ABSTRACT

An apparatus is provided for infusing saline solution through the ductal system of the human breast, the apparatus comprising a cup having outer and inner sidewalls defining a peripheral and a central recess opening into the mouth of the cup with openings in the cup for drawing a vacuum in each of the recesses to sealingly attach the apparatus to the breast over the nipple and and enable infusion of solution into the breast ductal system. A method for detection of cancer of the breast is provided by drawing a vacuum around the breast nipple, then irrigating the breast ducts with saline solution infused through the nipple and thereafter examining epithelial cells in the saline solution following irrigation for abnormalities.

United States Patent [72] Inventor Otto W. Sartorius Santa Barbara,Calif. 21 Appl. No. 801,613 [22] Filed Feb. 24,1969 [45] Patented Sept.28, 1971 [73] Assignee St. Croix Research Company St. Paul, Minn.

[54] METHOD AND APPARATUS FOR AIDING IN THE DETECTION OF BREAST CANCER10 Claims, 5 Drawing Figs. [52] us. Cl. 128]: R, 128/241, 128/248 [51]Int. Cl ..A61b 10/00 [50] Field of Search 12812, 280, 231, 300, 240,241, 24s, 66

[56] References Cited UNITED STATES PATENTS 3,527,203 9/1970 Gravlee128/2 2,655,145 10/1953 I-Ieger 128/300 X 2,771,072 11/1956 De Montauge128/241 /0 24 l 24. 34- /Z 32 Z2 42. 26 46 28 3a 3,096,764 7/1963Uddenberg 128/241 3,207,150 9/1965 Uddenberg 128/2 FOREIGN PATENTS148,449 9/1952 Australia 128/280 686,367 1/1953 Great Britain 128/281Primary Examiner-Richard A. Gaudet Assistant Examiner-Kyle L. HowellAttorney-Donald M. Sell ABSTRACT: An apparatus is provided for infusingsaline solution through the ductal system of the human breast, theapparatus comprising a cup having outer and inner sidewalls defining aperipheral and a central recess opening into the mouth of the cup withopenings in the cup for drawing a vacuumin each of the recesses tosealingly attach the apparatus to the breast over the nipple and andenable infusion of solution into the breast ductal system. A method fordetection of cancer of the breast is provided by drawing a vacuum Iaround the breast nipple, then irrigating the breast ducts with salinesolution infused through the nipple and thereafter examining epithelialcells in the saline solution following irrigation for abnormalities.

METHOD AND APPARATUS FOR AIDING IN THE DETECTION OF BREAST CANCER Thepresent invention relates to a method and apparatus for aiding in thedetection of breast cancer in females. More particularly, this inventionprovides a method for obtaining epithelial cells from the lining of thebreast ducts and a device for practicing this method.

Breast cancer ranks as the number one malignancy in the humanfemale andaccounts for approximately one-fourth of all cancers in women. Studieshave shown a definite correlation between the size of the originalcancer or lesion at the time of diagnosis and the mortality rates forcancers of the breast. The smaller the size of the lesion, the morelikely the recovery of the patient.

At the present time, early diagnosis of possible breast cancer isusually conducted by touch, and/or mammograms (breast X-rays) todetermine the presence of suspicious breast lesions. Upon detection oflesions the differential diagnosis between benign lesions and malignantlesions in the female breast is generally confirmed by biopsy done undergeneral anesthesia in a hospital. Only about one in four lesions isfound to be malignant and the prognosis for cancer of the breast hasimproved very little over the last several decades. The diagnosticprocedure, being cumbersome, costly and time consuming, is done onlywhen circumstances, such as discovery of an unusual lump in the breast,arouse sufficient suspicion on the part of the physician to warrant thepain and inconvenience of a biopsy to the patient.

The present invention is believed to provide a detection method forbreast cancer which can be used in routine physical examinations andinvolves little discomfort to the patient.

This invention provides a detection method for breast cancer as valuableas the routine Pap" smear now used for the early diagnosis of uterinecancer.

Natural secretions from the breast are an uncommon symptom of breastcancer, and even if present may or may not contain cancer cells. Thus,even though it has been known that breast cancer begins in the lumna ofthe ductal system of the breast, no way has heretofore been presentedfor obtaining cells from the lining of the ducts themselves.

The present invention provides a method to infuse a liquid into thebreast ducts to irrigate the ductal system and cause epithelial cellsfrom the duct lining to be dispersed therein and withdrawn with theirrigating liquid from the breast. The invention also provides a uniquedisposable apparatus for practicing the method.

Briefly, the method of this inventionfor the detection of breast cancerin the human female, and other female mammals having similar breaststructures, comprises l dilation of the nipple of the breast to distendthe breast duct openings which open thereinto, (2) infusion of anaseptic physiologically inert free-flowing liquid into said breast ductsthrough the dilated nipple openings to irrigatethe ducts and causeepithelial cells lining the ducts to slough off and disperse in theirrigating liquid'and (3) withdrawal of the irrigating liquid from thedilated nipple openings for microscopic examination of epithelial cellsdispersed therein the ascertain whether or not any are malignant.

The apparatus of the invention for practicing the method may comprise acup having a continuous outer sidewall and a continuous inner sidewallspaced therefrom defining a continuous peripheral recess and a centralrecess, both opening into the mouth of the cup. The cup is adapted sothat as it is pressed against the breast the peripheral recess surroundsthe nipple area and the nipple is received within the central recess.The cup has openings therein for drawing a vacuum in each of saidrecesses to seal the cup against the breast and to dilate the nipple ofthe breast received within the central recess of the cup. The cup isprovided with vacuum openings into the peripheral and central recessesto seal the cupto the breast. Liquid infusion and air vent openings alsoopen into the central recess whereby liquid can be infused into andwithdrawn from the breast ducts through the dilated nipple,

the vent opening permitting release of trapped air from the centralrecess as liquid is infused thereinto.

A presently preferred apparatus of the present invention for infusingthe breast duets with irrigating liquid and withdrawing the irrigatingliquid therefrom comprises generally a circular cup having a continuousouter sidewall and a continuous inner sidewall concentric therewithdefining a peripheral recess and a central recess opening into the mouthof the cup with the central recess being deeper than the peripheralrecess, the cup having a bottom forming a hollow chamber surrounding theportion of the inner sidewall depending below the floor of theperipheral recess. The continuous inner sidewall has openingstherearound above the floor of the central recess and below the floor ofthe peripheral recess at spaced intervals therearound communicatingwiththe hollow chamber. The cup further has a liquid infusion passage and anair-venting passage, which may also serve as a liquid withdrawalpassage, opening into the central recess and a vacuum 'drawing passageopening into the peripheral recess.

The practice of the method and the construction of the presentlypreferred form of apparatus for practicing the method are described inmore detail with reference to the accompanying drawing wherein:

FIG. 1 is a perspective view of the liquid infusion apparatus of thepresent invention;

FIG. '2 is a cross-sectional view of the device of FIG. 1 on an (takensubstantially along the plane of section line 22 of FIG.

FIG. 3 is a bottom view of the device of FIG. 1;

FIG. 4 is a side view of the device illustrated in approximately actualsize, with parts being broken away for clarity of detail, in'positionagainst a breast to begin practice of the method of the invention;

FIG. 5 is a view similar to FIG. 4 on an enlarged scale with the devicein position and functioning in the practice of the method of theinvention.

Referring first to FIG. 1 of the drawing, a presently preferred form ofapparatus or device is illustrated for infusing the breast ducts of ahuman female with an irrigating liquid and withdrawing'the irrigatingliquid therefrom; The device is seen to comprise a-cup 10 having acontinuous outer sidewall 12 and a continuous inner sidewall 14, whichdefine respectively a peripheral recess 16 and a central recess 18opening into the mouth of the cup. The floor 20 of the peripheral recess16 is above the floor 22 of the central recess 18 so that the peripheralrecess 16 is considerably shallower than the central recess 18. Bottom24 closes the bottom of the cup 10.

Because the cup- 10 illustrated in the preferred embodiment is generallycylindrical, the outer sidewall 12 and the inner sidewall 14 havecircular peripheries and form concentric tubes with the peripheralrecess 16 being in the form of an annular channel and the central recess18 being in the form of a cylindrical bore. Opening circumferentiallyaround the inner sidewall 14 below the flat floor 20 of the peripheralrecess 16 and above the flat floor 22 of the central recess are aplurality of passages 26. Further, opening into the floor 20 of theperipheral recess 16 is a vacuum-drawing passage 28 and opening into thefloor 22 of the central recess l8-are liquid infusion passage 30 andair-venting passage 32, respectively. Liquid can bewithdrawn from eitherpassage 30 or 32. There is one further vacuum drawing passage in the cup10, which does not appear in FIG. 1 although the flexible tubingconnecting means for the passage is visible as tapered rigid tubularshaft 34 depending from the bottom 24 of the cup 10.

Turning now to FIG. 2, the construction of the cup 10 is illustrated inmore detail. As is apparent from this figure an annular chamber 36 isformed within the cup 10, which annular chamber surrounds the lowerportion of the recess 18. The circumferential ope.nings26'through thesidewall 14, separating the inner and outer recesses 16 and 18, openinto this annular chamber 36. The connecting means 34 opens into apassage 40 which in turn opens into the hollow closed annular chamber 36surrounding the lower portion of the inner recess 18 of the cup 10. Asis also apparent in this figure, the vacuum-drawing passage 28 openinginto the floor 20 of the peripheral recess 16 of the cup opens at itsother end into the bottom of the cup where it connects to a taperedrigid shaft 38 depending from the bottom 24 of the cup, which shaft is aconnecting means for connecting passage 28 with a piece of tubing asdoes each of the other connecting means 34, 42 and 44. Because of theway FIG. 2 is sectioned, the passage 32 does not appear as it is not inthe cross-sectional detail.

As appears most clearly in FIG. 3, passages 30 and 32 opening into thefloor 22 of the central recess 18 likewise open through the bottom 24 ofcup into the rigid tapered tubular shafts forming connecting means 42and 44, respectively. Conveniently, the passages open through the bottom24 of the cup in the manner illustrated; however, this is of course amatter of choice and they may open through the sidewall 12 or throughsome combination of the sidewall 12 and the bottom 24.

The cup 10 is preferably composed entirely of a clear, transparentplastic so that the physician can observe the procedure as it takesplace; an acrylic resin such as polymethyl methacrylate has been foundquite suitable. Polyamides, vinyls and olefins may also be used-as maythermosetting plastics.

Turning now to FIGS. 4 and 5, the practice of the method and the use ofthe device 10 in such practice are more particularly described. In FIG.4 the device 10 is shown in approximately its actual size whereas in theother figures of the drawing the device is shown in various degrees ofenlargement for ease of pictorial representation. Prior to placement ofthe device against the breast it is connected to the auxiliary equipmentillustrated schematically in FIG. 5, which will be described in moredetail hereafter.

First the breast 46 and the nipple 48 are cleansed with a 70 percentalcohol solution. Next, tincture of benzene or a nonallergenic skinadhesive is applied to the cleansed area around the nipple. Then, asillustrated in FIG. 4 the device 10 is placed against the breast 46 withthe nipple 48 received in the central recess 18 of the device.

Next. a sufficient vacuum is drawn in the peripheral recess 16 of thedevice to seal it to the skin of the breast 46 around the nipple. Thismay be done by connecting flexible tubing 50 from the connection 38 to avacuum pump P; a sufficient vacuum is indicated when the skin isobserved to be drawn into the recess 16 as illustrated. Valve 52 may beused to maintain or release the vacuum.

Suction is then drawn in the central recess 18 by withdrawing airthrough the apertures 26 by means of tube 54 leading from the connection34 to the vacuum pump P; sufficient suction is achieved when the nippleis sufficiently dilated circumferentially to seat firmly against theinner surface of the wall 14 of the recess 18 and seal off the apertures26 as illustrated in FIG. 5. Valve 56 may be used to maintain or releasethe suction on the nipple.

Then, a 9/10 of 1 percent standard saline solution is infused into thebreast through the dilated breast nipple 48 from a saline infusionvessel I by means of tube 58 leading therefrom to a valve V, and thenceto the central recess 18 of the device 10 by means of tubing 60 leadingto connection 42. The valve V may be closed or may selectively (0)connect the vessel I with recess 18, and (b) connect recess 18 with thesaline withdrawal tube 62 from which saline from the breast 46 may becollected. Of course, when saline is being withdrawn from the breast,flow of saline into the breast from the vessel I is halted by the valveV. The vessel I is further connected to a 50 centimeter manomoter M bymeans of tube 64.

The air vent 32 is connected through connection 44 to tube 66 which isinterrupted l valve 68. In the infusion of the breast, sufficient salinesolution is introduced into recess 18 while valve 68 is open to releasetrapped air therefrom and replace the air with saline solution. Valve 68is then closed. After release of trapped air from the recess 18, theinfusion vessel I is elevated to register about 40 centimeters pressureon the manometer scale and saline is infused into the breast ducts. Thevalve V is then closed, and the saline infusion unit I lowered. Valve Vis then opened to its (b) position and about 1 c.c. of fluid is allowedto escape from the duct system of the breast through the withdrawal tube62. The valve V is then returned to its open position (a) after thevessel 1 is raised and the manometer reading registers 40 centimeters.Liquid is then again infused into the breast, the valve V closed, thevessel I lowered, and the valve V opened to position (b) to withdraw asecond cubic centimeter of saline from the breast ducts. This procedureis again repeated, and the third centimeter of fluid removed from thebreast duct system is prepared pathologically for cell examination.Throughout the procedure the nipple 48 is maintained in its dilatedcondition.

That which is claim is:

l. A method for the detection of breast cancer in female mammalscomprising (1) dilating the nipple of the breast to distend the breastduct openings therethrough, (2) infusing an aseptic physiologicallyinert free-flowing liquid into said breast ducts through said dilatednipple openings to irrigate said ducts and cause epithelial cells liningsaid breast ducts to slough off and disperse in said liquid, and (3)withdrawing said irrigating liquid from said nipple openings forexamination of the epithelial cells dispersed therein.

2. A method for the detection of breast cancer in the human femalecomprising l) forming a seal around the nipple of the breast, 2) drawinga vacuum around said nipple within the sealed area to dilate said nippleand distend the breast duct openings therein, 3) infusing an asepticphysiologically inert free flowing liquid into said breast ducts throughsaid distended nipple openings to irrigate said ducts and causeepithelial cells lining said ducts to slough off and become dispersed insaid liquid, and (4) withdrawing said liquid from said nipple openingsfor examination of the epithelial cells dispersed therein.

3. The method of claim 2 wherein said nipple dilating vacuum is drawnaround the circumferential periphery of said nipple.

4. The method of claim 2 wherein said liquid is an aqueous salinesolution.

5. A device for use in an apparatus for infusing the breast ducts of amammalian female with an irrigating liquid and then withdrawing theirrigating liquid therefrom, said device comprising a cup having acontinuous outer sidewall and a continuous inner sidewall defining aperipheral recess and a central recess opening into the top of said cup,said central recess being deeper than said peripheral recess, said cuphaving a bottom forming a hollow chamber surrounding the portion of saidinner wall extending below said peripheral recess, said continuous innersidewall having openings at spaced intervals therearound communicatingsaid central recess and said chamber, said cup having liquid infusionand liquid withdrawal passages opening into said central recess, andhaving vacuum passages opening into said chamber and said peripheralrecess.

6. A device suitable for use in an apparatus for irrigating the breastducts of the human female comprising a cup having outer and innerconcentric continuous sidewalls forming an outer annular recess and acentral recess, the floor of said central recess being below the floorof said peripheral recess, said cup having a bottom below the floors ofsaid recesses and having a hollow chamber formed therein, said innersidewall having a plurality of openings spaced circumferentiallytherearound communicating said central recess and said hollow chamberwith one another, said cup having liquid infusion and liquid withdrawalpassages opening into the floor of said central recess, and havingvacuum drawing passages opening into said chamber and said annularrecess.

7. The device of claim 6 wherein said cup has means thereon forfacilitating the connection of tubing to said passages.

8. The device of claim 7 wherein said means are provided on the bottomof said cup.

9. A device for use in an apparatus for the infusion of a liquid intothe breast ducts of a human female and for withdrawing the liquid soinfused, said device comprising a cup having a continuous outer sidewalland a continuous inner sidewall defining a peripheral recess and acentral recess opening into the mouth thereof, said cup having openingstherein for drawing a vacuum in each of said recesses when the mouth ofsaid cup is pressed against the breast, said central recess beingadapted to receive the nipple of the breast and to enable the same todilate as a vacuum is drawn therewithin,

2. A method for the detection of breast cancer in the human femalecomprising ( 1) forming a seal around the nipple of the breast, ( 2)drawing a vacuum around said nipple within the sealed area to dilatesaid nipple and distend the breast duct openings therein, ( 3) infusingan aseptic physiologically inert free flowing liquid into said breastducts through said distended nipple openings to irrigate said ducts andcause epitHelial cells lining said ducts to slough off and becomedispersed in said liquid, and (4) withdrawing said liquid from saidnipple openings for examination of the epithelial cells dispersedtherein.
 3. The method of claim 2 wherein said nipple dilating vacuum isdrawn around the circumferential periphery of said nipple.
 4. The methodof claim 2 wherein said liquid is an aqueous saline solution.
 5. Adevice for use in an apparatus for infusing the breast ducts of amammalian female with an irrigating liquid and then withdrawing theirrigating liquid therefrom, said device comprising a cup having acontinuous outer sidewall and a continuous inner sidewall defining aperipheral recess and a central recess opening into the top of said cup,said central recess being deeper than said peripheral recess, said cuphaving a bottom forming a hollow chamber surrounding the portion of saidinner wall extending below said peripheral recess, said continuous innersidewall having openings at spaced intervals therearound communicatingsaid central recess and said chamber, said cup having liquid infusionand liquid withdrawal passages opening into said central recess, andhaving vacuum passages opening into said chamber and said peripheralrecess.
 6. A device suitable for use in an apparatus for irrigating thebreast ducts of the human female comprising a cup having outer and innerconcentric continuous sidewalls forming an outer annular recess and acentral recess, the floor of said central recess being below the floorof said peripheral recess, said cup having a bottom below the floors ofsaid recesses and having a hollow chamber formed therein, said innersidewall having a plurality of openings spaced circumferentiallytherearound communicating said central recess and said hollow chamberwith one another, said cup having liquid infusion and liquid withdrawalpassages opening into the floor of said central recess, and havingvacuum drawing passages opening into said chamber and said annularrecess.
 7. The device of claim 6 wherein said cup has means thereon forfacilitating the connection of tubing to said passages.
 8. The device ofclaim 7 wherein said means are provided on the bottom of said cup.
 9. Adevice for use in an apparatus for the infusion of a liquid into thebreast ducts of a human female and for withdrawing the liquid soinfused, said device comprising a cup having a continuous outer sidewalland a continuous inner sidewall defining a peripheral recess and acentral recess opening into the mouth thereof, said cup having openingstherein for drawing a vacuum in each of said recesses when the mouth ofsaid cup is pressed against the breast, said central recess beingadapted to receive the nipple of the breast and to enable the same todilate as a vacuum is drawn therewithin, said cup having a furtheropening therein into said central recess for infusing liquid thereinto,said cup having a further opening therein into said central recess tovent air therefrom as liquid is infused thereinto.
 10. The apparatus ofclaim 9 wherein the openings for drawing a vacuum in said central recessare circumferentially spaced around the wall defining the recess andabove the floor of the recess so as to draw the nipple into peripheralcontact with such wall as suction is applied through said openings.